Homepage » Pharma »

Package leak testing receives FDA approval

Mass Extraction leak testing process meets FDA standard F3287
Package leak testing receives FDA approval

pfeiffer-vacuum-ATC-ME2-cmyk.jpg
FDA laboratories in the US and major pharmaceutical companies have been using the Mass Extraction instruments for over 10 years Picture: Pfeiffer Vacuum
Advertisement

The ATC by Pfeiffer Vacuum Mass Extraction leak testing process meets FDA standard F3287 for leak testing. This shortens the FDA approval process for pharmaceutical products that require leak testing significantly. However, with ATC being added to the FDA standard, companies do not need to submit paperwork regarding leak test, test procedure, water ingress, and package testing manufacturers can simply declare that their product is leak tested in accordance with FDA F3287 by using ATC equipment, thus adhering to the standard.

USP 1207 and ASTM (F-3287–17) recognized ATC Mass Extraction Technology works on the principle of rarefied gas flow. Testing takes place in vacuum conditions to attain higher sensitivity. This patented technology is particularly suitable for pharmaceutical packaging such as IV-bags, pouches or glass vials. Larger defects and defects as small as 1 μm can be detected with this method. The technology is thereby suitable for laboratory applications as well as for use in production environments allowing stability control as well as 100% automated testing (also in inline machines).

Advertisement
Current issue
Titelbild cpp chemical plants   processes 2
Issue
2.2020
READ
Headlines
Processes below 100°C controlled by vacuum steam
Cold steam
All Whitepaper

All whitepapers of our industry pages

Current Whitepaper

New filtration technology for highly corrosive media

Advertisement
Advertisement

Industrie.de Infoservice
Vielen Dank für Ihre Bestellung!
Sie erhalten in Kürze eine Bestätigung per E-Mail.
Von Ihnen ausgesucht:
Weitere Informationen gewünscht?
Einfach neue Dokumente auswählen
und zuletzt Adresse eingeben.
Wie funktioniert der Industrie.de Infoservice?
Zur Hilfeseite »
Ihre Adresse:














Die Konradin Verlag Robert Kohlhammer GmbH erhebt, verarbeitet und nutzt die Daten, die der Nutzer bei der Registrierung zum Industrie.de Infoservice freiwillig zur Verfügung stellt, zum Zwecke der Erfüllung dieses Nutzungsverhältnisses. Der Nutzer erhält damit Zugang zu den Dokumenten des Industrie.de Infoservice.
AGB
datenschutz-online@konradin.de